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Vijay B. Samant, Vical's President and Chief Executive Officer, said, "Aswe advance toward completion of enrollment in our Phase 3 trial ofAllovectin-7(R) in patients with advanced metastatic melanoma, we are alsolooking ahead to commercialization opportunities in key global markets. As anestablished pharmaceutical company in Turkey with a significant cancerfranchise, EIP has the expertise to guide Allovectin-7(R) through the Turkishapproval process and the strength to launch and sell Allovectin-7(R)successfully in the Turkish market. We continue to explore licensing anddistribution agreements in additional international markets."
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About Allovectin-7(R)
Allovectin-7(R) is a plasmid/lipid complex containing the DNA sequencesencoding HLA-B7 and beta-2 microglobulin, which together form a Class I MajorHistocompatibility Complex, or MHC-I antigen. Injection of Allovectin-7(R)directly into tumors is designed to stimulate an immune response against bothlocal and distant metastatic tumors. Vical conducted a large Phase 2 trialevaluating Allovectin-7(R) immunotherapeutic as a single agent for patientswith Stage III or IV metastatic melanoma. Based on advice from clinicalexperts and detailed guidance received from the U.S. Food and DrugAdministration (FDA) in an End-of-Phase 2 meeting, Vical successfullycompleted a Special Protocol Assessment (SPA) with the FDA for a Phase 3 trial(the Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma, or AIMM trial)for certain patients with Stage III or Stage IV metastatic melanoma. The SPAagreement specifies that the trial design and planned analyses address thestudy's objectives and the resulting study data could provide the primarybasis to support a product license application.
Allovectin-7(R) has been granted orphan drug designation for the treatmentof invasive and metastatic melanoma by the FDA's Office of Orphan ProductsDevelopment. Orphan drug designation provides U.S. marketing exclusivity forseven years if marketing approval is received from the FDA, in addition tocertain tax benefits for qualifying expenses.
About the AIMM Trial
Vical is conducting a Phase 3 pivotal trial of the company'sAllovectin-7(R) cancer immunotherapeutic as first-line therapy inchemotherapy-naive patients with Stage III or IV metastatic melanoma. The AIMMtrial is being conducted in accordance with the SPA agreement at more than 60clinical sites, and is currently enrolling patients in the United States,Canada and Europe. AnGes MG, Inc., is funding the clinical trial under acollaborative agreement with Vical.
The AIMM trial calls for enrollment of approximately 375 patients withStage III or IV metastatic melanoma. Patients may have been previously treatedwith surgery, adjuvant therapy, and/or biotherapy, but cannot have beenpreviously treated with cytotoxic chemotherapy. The patients will berandomized on a 2:1 basis: approximately 250 patients will be treated withAllovectin-7(R) and approximately 125 will be treated with their physician'schoice of either of two chemotherapy agents, dacarbazine or temozolomide. Theprimary endpoint is a variation of progression-free survival, specificallycomparison of objective response rates at six months or more afterrandomization. The study will also evaluate safety and tolerability as well asoverall survival. A patient self-screening tool for trial eligibility isavailable online at www.melanomaclinicaltrial.com.
About Metastatic Melanoma
The American Cancer Society has estimated that more than 62,000 newdiagnoses of, and approximately 8,400 deaths from, melanoma will occur in 2008in the United States. Currently, there are no consistently effective therapiesfor advanced cases of metastatic melanoma where the cancer has spread to otherparts of the body. The toxicity associated with FDA-approved treatments suchas dacarbazine or interleukin-2 is often significant, resulting in serious orlife-threatening side effects in many of the patients treated. Patients withmetastatic melanoma often are treated off-label with drugs such astemozolomide, which has been approved by the FDA for the treatment of certaintypes of brain cancer but not for the treatment of metastatic melanoma.Temozolomide is an orally-delivered pro-drug that converts in the body intothe same active compound as dacarbazine.
About EIP
EIP is part of the Eczacibasi Group, a prominent Turkish industrial groupof companies primarily involved in healthcare, consumer products, and buildingproducts. EIP focuses on sales and marketing of imported pharmaceuticals inspecific therapeutic areas and has multiple licensing agreements with leadingbiotech and pharmaceutical companies.
About Vical
Vical researches and develops biopharmaceutical products based on itspatented DNA delivery technologies for the prevention and treatment of seriousor life-threatening diseases. Potential applications of the company's DNAdelivery technology include DNA immunotherapeutics for cancer, in which theexpressed protein is an immune system stimulant; DNA vaccines for infectiousdiseases, in which the expressed protein is an immunogen; and cardiovasculartherapies, in which the expressed protein is an angiogenic growth factor. Thecompany is developing certain infectious disease vaccines and cancertherapeutics internally. In addition, the company collaborates with majorpharmaceutical companies and biotechnology companies that give it access tocomplementary technologies or greater resources. These strategic partnershipsprovide the company with mutually beneficial opportunities to expand itsproduct pipeline and serve significant unmet medical needs. Additionalinformation on Vical is available at www.vical.com.
This press release contains forward-looking statements subject to risksand uncertainties that could cause actual results to differ materially fromthose projected. Forward-looking statements include statements about the EIPagreement, Allovectin-7(R), and the AIMM trial. Risks and uncertaintiesinclude: whether EIP will obtain the necessary regulatory approvals for theTurkish territory; whether EIP will successfully sell and marketAllovectin-7(R) in Turkey and the Turkish Republic of Northern Cyprus; whetherVical will achieve any milestones and whether EIP will pay Vical any upfrontor milestone payments under the agreement; whether Vical or others willcontinue development of Allovectin-7(R); whether Vical will be able to recruitpatients into the AIMM trial as planned, if at all; whether Vical will receiveall of the clinical trial funding from AnGes under the collaborativeagreement; whether Allovectin-7(R) or any other product candidates will beshown to be safe and effective; the timing, nature and cost of clinicaltrials; whether Vical or its collaborative partners will seek or gain approvalto market any product candidates; whether Vical or its collaborative partnerswill succeed in marketing any product candidates; whether defined sales levelswill be achieved in any markets; and additional risks set forth in thecompany's filings with the Securities and Exchange Commission. Theseforward-looking statements represent the company's judgment as of the date ofthis release. The company disclaims, however, any intent or obligation toupdate these forward-looking statements.
Contact: Alan R. Engbring(858) 646-1127 Website: http://www.vical.com
SOURCE Vical Incorporated
